US5820607A - Multipurpose anti-microbial silastic sheath system for the prevention of device-related infections - Google Patents
Multipurpose anti-microbial silastic sheath system for the prevention of device-related infections Download PDFInfo
- Publication number
- US5820607A US5820607A US08/465,587 US46558795A US5820607A US 5820607 A US5820607 A US 5820607A US 46558795 A US46558795 A US 46558795A US 5820607 A US5820607 A US 5820607A
- Authority
- US
- United States
- Prior art keywords
- pharmacologically active
- catheter
- construct
- active agent
- tube
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/04—Macromolecular materials
- A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
- A61L29/085—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
- A61L29/16—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
- A61L2300/406—Antibiotics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/41—Anti-inflammatory agents, e.g. NSAIDs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/42—Anti-thrombotic agents, anticoagulants, anti-platelet agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/45—Mixtures of two or more drugs, e.g. synergistic mixtures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/63—Crystals
Definitions
- the present invention relates generally to the field of medical devices.
- One particular application concerns catheters with pharmacologically active ingredients layered between the lumen and external surfaces of the catheter, including their application and preparation.
- the invention also concerns the field of long-term infection control in medical devices, as the described devices possess extended antimicrobial activity and hence, extended capacity to prevent/inhibit infection.
- Catheters used for vascular access, both arterial and venous, urethral, abdominal cavity tubing, drainage bags and various connectors are common sources of infection.
- a high percentage of patients who require long-term urinary catheters develop chronic urinary tract infections, frequently in conjunction with episodes of fever, chills and flank pain.
- Such patients are at risk of developing bacteremia or chronic pyelonephritis, conditions of high morbidity and mortality.
- a desirable feature of urinary catheters is that they should provide some means of infection control.
- One way to control bacterial infections is by providing, concurrent with the catheter treatment, an antibiotic regimen.
- an antibiotic regimen In addition to providing antimicrobial agents to combat catheter-related infections, it is sometimes desirable to deliver other agents such as anticoagulants and antifibins as adjuncts to the antimicrobial agents to prevent thrombotic occlusions and microbial colonization on both the external and luminal surfaces.
- pharmacologically active ingredients be maintained for a long duration of time, released in a relatively slow manner, and that the delivery be circumferential with the catheter or device rather than concentrated in particular areas. It is even further desired that the incorporation of the pharmacologically active ingredients in a delivery system as described can be adapted to all catheters ranging from simple to complex ones, and from adult to pediatric sizes. This also includes the various medical devices this technology can advance.
- the antimicrobial agents released from the catheter when present prevented recolonization of the zone of inhibition for up to 90+ days.
- the surfactants used to facilitate bonding between the pharmacologically active ingredient and the catheter such as tridodoecl-methylammonium chloride (TIDMAC) or benzalkonium chloride, have limited effectiveness due to their short binding duration.
- TIDMAC tridodoecl-methylammonium chloride
- benzalkonium chloride have limited effectiveness due to their short binding duration.
- the direct contact between these pharmacologically active ingredients with biological fluids in such devices facilitates rapid depletion of the active ingredients.
- Wepsic et al. U.S. Pat. No. 3,598,127 relates to an antibacterial agent placed as a powder in longitudinal grooves between the catheter wall and a polysiloxane rubber layer.
- the polysiloxane layer was permeable to the antibacterial agent, allowing the agent to diffuse through the layer.
- the Wepsic et al. patent used longitudinally spaced grooves to contain the powdered bacterial agent. This is believed to be an undesirable and less effective arrangement, as it does not result in even diffusion around the circumference of the catheter or prolong the antimicrobial activity of the catheter beyond that of the surface coated catheters.
- the presence of the powder makes it very difficult to manufacture this design and reproduce a unit that consistently produces reproducible results. This is due in part to the uncontrolled powder concentration in the grooves.
- the present invention is directed to providing such a solution.
- the present invention seeks to overcome these and other drawbacks inherent in the prior art by providing a device that is surrounded with a layer of pharmacologically active ingredient which, in turn, is surrounded by an outer sheath composed of silicone.
- This layer is permeable to the pharmacologically active ingredients, yet provides a safety barrier between the pharmacologically active ingredients embedded in the device and the surrounding biological fluids.
- the devices of the present invention also provide the advantage of allowing diffusion of the pharmacologically active ingredient both into the lumen of the device and outward to the exterior surface of the device.
- the present invention comprises an indwelling medical device having an elongated, hollow lumen, providing an inner shell to the device.
- This inner shell is surrounded by selected pharmacologically active ingredients.
- These ingredients may either be suspended in, for example, silicone, or take the form of a powder layer.
- These pharmacologically active ingredients are surrounded by an outer solid sheath of silicone, or other pharmacological-agent permeable material. The ingredients may thus slowly diffuse through the inner sheath and/or outer sheath. The diffusion of the pharmacologically active ingredients through the outer sheath provides a circumferential layer on the surface of the device to inhibit microbial colonization.
- the outer sheath is constructed from polysiloxane rubber.
- An alternative embodiment of the present invention uses a jacket of silicone impregnated with at least one pharmacologically active ingredient as a sandwiched layer between the inner surface that surrounds the lumen, and the external layer comprising the sheath, in lieu of a "sandwiched" crystalline layer of pharmacologically active ingredient.
- the present invention provides an indwelling medical device which incorporates a system for delivering pharmacologically active ingredients in a slow, controlled manner over a long duration of time.
- pharmacologically active ingredients are evenly distributed around the entire circumference of the device.
- the present invention may be adapted to all indwelling medical devices, and existing devices may be modified to contain the delivery system described by the present invention.
- antimicrobial jacket and surrounding outer sheath although are described for catheters, they can apply to any medically implantable device.
- the devices of the invention do not have to be constructed from permeable material, but may in some embodiments be constructed of semi-permeable materials, or a combination of both permeable and semi-permeable materials.
- Some embodiments of the device may be comprised of material that is less permeable than silicone, or not permeable at all, to the particular pharmacologically active agent used, yet the device can be surfaced with an antimicrobial agent bonded with silicone and covered with a silicone sheath.
- Such semi-permeable or non-permeable device materials include teflon, polyurethane, carbothane, polyethylene, tigan and various other plastic materials used in medical devices.
- the device of the invention may be fashioned to provide any variety of catheter desired, whether the catheters are constructed from permeable, semi-permeable or non-permeable materials. If drug diffusion is desired into both the lumen of the catheter and to the surface of the catheter, the catheter tube material selected should at least be semi-permeable to the pharmacologically active agent selected. If drug diffusion is desired to the surface of the catheter or device, such catheter tube or device material can be constructed from the various non-permeable plastics used in medical devices.
- the pharmacologically active substances of the catheter diffuse through the outer sheath and surround the outer circumference or surface of the catheter, thus providing a protective zone of antimicrobials.
- the inner jacket/coating of the catheter lumen is of a permeable or semi-permeable material
- the antimicrobial will also diffuse into the lumen of the catheter, thus providing still further anti-infection control and suppression of intrapumenal colonization of bacteria.
- FIG. 1 is a cross section of a catheter (1) according to the invention having a silicone sheath jacket on the exterior surface (2) with a pharmacologically active antimicrobial agent (crystalline form) (3) sandwiched by an inner (luminal) layer of silastic (4) that forms the lumen of the catheter (5).
- a pharmacologically active antimicrobial agent crystalline form
- FIG. 2 is a cross section of a catheter according to the present invention having a silastic sheath jacket on the exterior surface (6) with a pharmacologically active antimicrobial agent totally embedded in silicone to form layer (7) sandwiched by an inner (luminal) layer of silicone (i.e., an inner sheath) (8) that surrounds the lumen of the catheter (9).
- a silastic sheath jacket on the exterior surface (6) with a pharmacologically active antimicrobial agent totally embedded in silicone to form layer (7) sandwiched by an inner (luminal) layer of silicone (i.e., an inner sheath) (8) that surrounds the lumen of the catheter (9).
- FIG. 3 is a longitudinal cutaway of a catheter according to the present invention which contains a silicone jacket impregnated with a pharmacologically active ingredient (10), covered with an outer surface silicone sheath (11). Cutaway also shows inner luminal sheath (12).
- FIG. 4 is a longitudinal section of a catheter according to the present invention having a layer of pharmacologically active ingredients (13) and an outer sheath (14) which does not extend for the full length of the catheter.
- FIG. 5 is a longitudinal section of a catheter according to the present invention having a layer of pharmacologically active ingredients (15) and an outer sheath (16) coextensive with the length of the catheter.
- FIG. 6 demonstrates the effect of various sterilization methods on silicone sheathed antimicrobial (minocycline/rifampin; 2:1) inhibition. Zones of inhibition above 15 mm are considered as having significant antimicrobial activity.
- A Gas Sterilization;
- B Gamma Radiation Sterilized 2-3 Mega Rad;
- C Ethanol-dip sterilization.
- FIG. 7 shows the effect of various sterilization methods on silicone sheathed antimicrobial/anticoagulant (minocycline/EDTA; 2:1) catheters.
- FIG. 8 efficacy of silicone sheathed antimicrobial (minocycline/rifampin; 2:1) catheters.
- FIG. 9 shows a comparison of the long-term efficacy of 3 silicone sheathed antimicrobials to Arrow and Cook+minocycline-coated catheters.
- Minocycline/Rifampin 2:1 -- ⁇ --;
- Minocycline/Rifampin 2:1 -- ⁇ --;
- Minocycline/EDTA 2:1 ⁇ .multidot.;
- Arrow - ⁇ - ⁇ - ⁇ -;
- Cook+Minocycline -- ⁇ --.
- FIG. 11 shows a multi-lumen catheter that includes a single inner sheath (17) and a layer that includes a pharmacologically active ingredient (18) and an outer sheath (19).
- the drawing depicts a catheter device having five lumens (20).
- FIG. 12 shows antimicrobial activity after catheter removal.
- the indicated numbers 13d, 6d, 21d, 30d, 42d refer to the day, measured in days, after the catheter had been removed from the agar in an initial test for antimicrobial activity.
- Medical devices include any such devices that are indwelling in a patient or animal. Such devices include abdominal cavity drainage bags, connectors and tubing used by colostomy patients. Angioplasty devices also are included within the present invention. Preferred devices are catheters in including introducing, sensing and monitoring catheters. More preferred are urinary, venous, arterial, and peritoneal catheters, tracheotomy devices, shunts and other medical devices or prosthesis.
- a catheter (1) comprises a catheter lumen (5) defining a hollow fluid passage through which fluids may be administered or withdrawn from the patient.
- the catheter (1) being surrounded by a layer (3), of pharmacologically active agents. These pharmacologically active ingredient may be in crystalline form.
- the layer (3) is, in turn, surrounded by an outer sheath (2).
- This outer sheath (2) is in some embodiments at least partially permeable to the pharmacologically active agents.
- the permeability of the sheath (2) allows the pharmacologically active agents to diffuse out from the layer (3) and through the outer sheath (2) and eventually to surround the outer circumference of the catheter.
- the catheter (1) may be any standard catheter which is currently available. It is desirable that the catheter (1) be made of silicone or a like at least semi-permeable material when it is desirable for the pharmacological agents in layer (3) to also diffuse into the lumen of the catheter (5).
- the outer sheath (2) is constructed from a material which is at least partially permeable to the pharmacologically active agents in layer 3.
- the material used and the thickness of the outer sheath (2) will determine how rapidly the pharmacologically active ingredient will diffuse through the outer sheath (2) and into the surrounding environment.
- the selection of material for the outer sheath (2) will depend upon the particular application.
- the layer of pharmacologically active ingredients (15) and the outer sheath (16) may be coextensive with the underlying catheter (1) extending the entire length of the catheter as depicted in FIG. 5, or alternatively, may be limited to a portion of the catheter (1) which is in direct contact with the surrounding tissue, as depicted in FIG. 4.
- FIG. 2 An important alternative to using layer (3) in FIG. 1 is depicted in FIG. 2.
- the catheter (1) is surrounded by a layer of pharmacologically active ingredient embedded in a silicone jacket (7), which in turn is surrounded by an outer silicone sheath (6).
- the catheter (1) and outer sheath (6) serve to sandwich the pharmacologically active ingredient (7) as an integral part of the catheter construction.
- the concentration of the pharmacologically active ingredient, its density when embedded in the silicone (7) and the thickness of the outer sheath (6) will determine the rate at which the pharmacologically active ingredient in the silicone jacket (7) will diffuse through the outer sheath (6) and surround the surface of the catheter.
- the selection of the outer sheath (6) material will vary depending on the specific application. Again, it is preferred for the inner sheath surrounding the lumen of the catheter or the surface of the device to be made of silicone or similarly permeable or semi-permeable material if it is desirable for the pharmacological agents in the middle layer (7) to diffuse into the lumen (9) of the device.
- the layer of the pharmacologically active ingredient (15) and the outer sheath (16) may be coextensive with the catheter as depicted in FIG. 5 or may be limited in length to the area most directly in contact with the surrounding environment, such as a tissue, as depicted in FIG. 4.
- pharmacologically active ingredients may be used in preparing the devices of the present invention.
- Typical pharmacologically active ingredients include anticoagulants, antifibrin agents, antiinflammatory agents and antimicrobials.
- Anticoagulants included EGTA, EDTA, heparin, urokinase, streptokinase, and others.
- Antiinflammatory agents include steroids, nonsteroidal antiinflammatory agents, and salicylates.
- Antimicrobials include antibiotics antifungal and antiviral agents.
- Antibiotics include minocycline, rifampin, penicillins, cephaloporins, monobactams, carbapenems, clindamycin, chloramphenicol, tetracycline, quinolones, macrolides, sulfa antibiotics, trimethoprim, fusidic acid and aminoglycosides.
- Antiviral agents include acyclovir, ganciclovir, fosiornet and pencyclovir.
- Antifungal agents include amphotericin B, azoles, flucytosine, cilofungin and nikko Z.
- the composition and thickness of the outer sheath and, in certain embodiments the jacket will help determine how rapidly the pharmacologically active ingredient is released from its silicone matrix, through the outer sheath and for what period of time the pharmacologically active ingredient will continue to be released. It is contemplated that the sheath will be from 0.1 to 3 millimeters in thickness, preferably 0.2 to 0.4 mm.
- the jacket will range from 0.1 to 3 millimeters in thickness, preferably about 1 to about 2 mm, and in other embodiments, about 1.59 mm (actual size of jacket).
- the sheath will be from 0.1 mm to 1.5 mm in thickness, preferably 0.15 mm to 0.25 mm.
- the jacket will range from 0.1 mm to 3.0 mm in thickness, preferably 0.20 mm to 0.30 mm.
- the prototype catheter had a sheath that was prepared so as to have a thickness of about a 0.2 mm thickness for the inner luminal layer, middle jacket layer, and outer sheath, (middle jacket layer containing the pharmacologically active agents).
- the pharmacologically active ingredient(s) is embedded in the silicone.
- the outer sheath/jacket may, but need not be, made of the same material as the inner sheath that surrounds the catheter lumen. Suitable materials for the sheath and jacket include various silicone formulas. It has been found that polysiloxane rubber is useful in many applications. Polysiloxane materials are available commercially, and are known by the trade name SILASTIC (Dow Corning, Midland, Mich.; Baxter, McGaw Park, Ill.).
- the rate of release for the pharmacologically active ingredient is inversely proportional to the duration of release.
- the desired amount of ingredient released per unit of time will vary, as will the desired duration of release. For example, where the likelihood of infection is high, a correspondingly high level of antimicrobial release may be desired.
- a high rate of release (and short duration) is acceptable. In circumstances where the patient is sensitive to higher levels of the pharmacologically active ingredient, or where the device is in contact with the patient for an extended period of time, a lower release rate may be preferred.
- duration of release is the initial concentration of pharmacologically active ingredient in the device. Typically, the higher the initial concentration of the pharmacologically active agent, the longer the duration of release of the agent will be.
- the release rate is affected by the thickness of the outer sheath and the density of the materials used to construct the antimicrobial jacket, as discussed above.
- release rates it is well within the skill of those in the field to alter release rates in a variety of different ways. For example, it is possible to produce a delayed release profile, where little or no pharmacologically active ingredient is released initially, while allowing, after a predetermined period, substantial release of the included pharmacologically active ingredient. It also is possible to obtain "burst" release profiles, where the ingredient is delivered in concentrated bursts over an extended period. In still other embodiments, the device starts acting to release the pharmacologically active agent beginning at the time of insertion. Similarly, it is possible to produce stable, continuous levels of release over the same, extended periods.
- Contemplated release periods range from one minute to weeks and even months.
- the appropriate levels of release for given pharmacologically active ingredients may be determined by reference to standard medicinal formularies.
- compositions and methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the compositions and methods of this invention are described in terms of preferred embodiments, it will be apparent to those of skill in the art that variations may be applied to the composition, methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the invention. More specifically, it will be apparent that certain agents which are both chemically and physiologically related may be substituted for the agents described herein, while the same or similar results would be achieved. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims. The following examples are illustrative of the present invention but should not be considered, in any way, to be limiting.
- the present example demonstrates the methods that were used in the preparation of two prototypes of the sheath catheter.
- the prototypes were constructed from 3 cm segments of silastic tubing. Two types were made. The first type was made with micronized pharmacologic agents (crystalline powder) packed between two concentric silastic tubes. The second type was made from micronized pharmacologic agents compounded with clear RTV sealant silicone, and embedded as a sandwich between an outer layer (sheath) and an inner luminal layer of clear RTV sealant silicone layers.
- the first type was made with micronized pharmacologic agents (crystalline powder) packed between two concentric silastic tubes.
- the second type was made from micronized pharmacologic agents compounded with clear RTV sealant silicone, and embedded as a sandwich between an outer layer (sheath) and an inner luminal layer of clear RTV sealant silicone layers.
- the first type is similar to the cross-section shown in FIG. 1.
- the second type is similar to the cross-section shown in FIG. 2.
- the silastic tubing used for preparing the prototypes was Medical Grade Tubing (Dow Corning Silastic ®Brand, Cat No. 602-305). Other tubing used included a "Silicone Tubing" (Baxter, S/PTM Medical Grade, Cat T5715; McGaw Park, Ill.).
- the sealant used in preparing the devices was the 732TM Multipurpose Sealant, a 100% silicone rubber (Dow Corning®, Midland, Mich.). This material was used to seal the ends of the catheters as shown in FIG. 1. This silicone was also used to prepare the antimicrobial jacket layer (7) in FIG. 2, and was used to mold the sheath (6) and the lumen (8) layers of the catheter structure.
- Step 1 Tube 2 is slipped into tube 1.
- One end of the double tube was plugged with the silicone sealant, RTV 732 (Dow Corning, Midland, Mich.).
- Step 2 A pocket or layer was formed between tube 1 and 2. This space was packed with micronized pharmacologic agent, minocycline, rifampin, minocycline/rifampin, minocycline/EDTA, EDTA, Fusidic acid, gentamycin, aztreonam, minocycline/aztreonam.
- Step 3 When the segment is filled with the pharmacologic agent, the open end of the segment was sealed in the space between tubes 1 and 2.
- silastic medical adhesive type A (Dow Corning, Cat No. 891);
- RTV Sealant No. 732 (Dow Corning Corporation Medical Products--Midland, Mich. 48640)
- the second prototype produced is demonstrated in FIG. 2.
- the pharmacologically active agent is compounded in a silicone matrix. This combination of silicone and pharmacological agent was used to provide a layer around the tube as described below. Also, the most preferred pharmacological agents used were minocycline/rifampin and minocycline.
- This catheter was made in two different steps:
- Step 1 A pharmacologic agent-containing silicone was fashioned like a jacket around the silastic tube.
- Step 2 A silicone sheath was molded over the pharmacologically agent-containing jacket of step 1.
- the bores in the molds used to prepare the device were precisely drilled to specification, honed and polished in order to prevent the silicone from adhering to it.
- Step 1 A small silastic tube (0.8 mm I.D./1.7 mm O.D.) was used as the central luminal portion of the catheter.
- Step 2 A mold with bore size 2.77 mm was used most often to form the jacket layer of material containing the pharmacologically active agents (i.e., antimicrobial agents).
- Step 3 Preparation of the pharmacologically active agent containing material: Micronized minocycline/rifampin (2:1) in a concentration of 120 mg minocycline and 60 mg rifampin per gram of RTV silicone 732 sealant were mixed thoroughly. This mixture was spread into the bore surfaces of both halves of the mold.
- Step 4 The silastic tube in Step 1 (1.7 mm O.D.) was pressed and aligned central in the bore of the mold and both mold surfaces pressed together with a vice or clamp.
- Step 5 After catalysis was complete (about 30 min.), the mold halves were pried apart and the catheter was released. The catheter now included a jacket of the pharmacologically active ingredient bonded to the silastic tubing.
- Step 6 Excess material was trimmed from the jacket surface.
- Step 7 A mold with bore size 2.95 mm was used and RTV silicone 732 was spread into the bore surfaces of both halves of the mold.
- Step 8 The jacket of Step 5 containing the pharmacologically active agents was centrally placed in the bore of the mold containing the RTV sealant (prepared in Step 7) and the mold halves pressed together with a vice or clamp.
- Step 9 After catalysis was complete (about 30 min.) the mold haves were pried apart and the completed catheter was released. The catheter now included a silicone sheath over the jacket containing the pharmacologically active agent.
- Step 10 The excess material was trimmed from the catheter.
- the catheter was allowed to rest for several days to allow the catalytic products to dissipate before plating them.
- the outside diameter of the catheter was 2.95 mm.
- the above diameter sizes do not represent preferred or even typical dimensions of the catheters of the present invention. Moreover, the particular dimensions of the above prototypes are not considered the ideal sizes for manufacturing dimensions. The sizes were selected as representative only of standard dimensions for the present studies, and particularly for the studies conducted in the following examples, using the device as diagramed in FIG. 2.
- the efficacy of the prototype catheter segment was established by determining its ability to inhibit microbial growth expressed as "zone of inhibition.”
- the procedure involved sterilizing the catheters with ethylene oxide gas.
- Staphylococcus epidermis (SE-5667) was subcultured to a blood agar plate from frozen stock of SE-5667 (obtained from a patient with a blood strain infected with S. epidermidis).
- the catheter used here is the same as FIG. 2 and prototype 2.
- the present example demonstrates the anti-microbial activity observed with catheters that include the herein disclosed internal layer of pharmacologically active substances embedded in silicone and presented as a jacket sandwiched between two layers of silicone as demonstrated in FIG. 2.
- Staphylococcus epidermis (SE) strain 5667 was subcultured to a blood agar plate (BAP) from a frozen stock as described in Example 2. Five to ten colonies of SE were subcloned into three 5 ml tubes and incubated for two hours. Three flasks of Muellar Hinton agar, 500 ml each, were prepared and autoclaved. After cooling, one of the 5 ml tubes was added to each of the Muellar Hinton agar flasks. The flasks were mixed gently by swirling, and a small amount of the infected agar was poured into petri dishes, enough to cover the bottom of the plates.
- the submerged segments diffused the antimicrobial content along the entire circumferential surface of the sheath.
- the zones of inhibition observed were significant and continued to be so after multiple replatings of the same catheter segments.
- a silicone sheathed catheter containing minocycline and rifampin powder and embedded in silicone (FIG. 1 and FIG. 2), maintained a zone of inhibition of 35 mm.
- a zone of at least 15 mm has been correlated with in vivo efficacy 9 .
- the present example outlines the preparation of commercial embodiments of the invention.
- the 3 layers of the catheter will be extruded simultaneously, with all layers contributing to the catheter lining thickness and overall structural integrity.
- the various layers of these catheters are depicted in FIG. 2.
- the two outermost layers, the outer sheath and middle antimicrobial jacket can be utilized in constructing any medical device or prosthesis to inhibit and/or prevent device-related infections. This is accomplished by bonding these layers to the surface of any device where such device is implanted and in contact with body fluids.
- the catheter is to be extruded through an silicone extrusion machine, with the appropriate specialized tooling needed to force the antimicrobial components at a specified rate and thickness between the inner and outer silicone or other similarly permeable or semi-permeable layers of the device.
- This will produce a uniform internal "sandwiched" layer of the selected pharmacologically active agent (i.e., antimicrobial) throughout the device.
- the extrusion of the luminal tubes and the injection of the sheath is to occur in one single step.
- These three layers produce a sandwiched antimicrobial catheter (FIG. 2) with an interior lumen (9) surrounded by a silicone layer (8) and a middle jacket (7) and an exterior silicone sheath (6).
- the thicknesses of each layer is specified according to application and need.
- the "tubing" is to be cut at specified lengths and fitted with other standard structural components of an insertable device to form a usable unit prior to use.
- the "tubing" section is to be in some embodiments fitted with a silicone tip and a silicone-plastic manifold. Where multi luminal catheters are constructed (see FIG. 11), a multi-manifold unit is to be attached to the end of the pharmacological active agent/silicone coated tube to form a completed catheter ready for use.
- the pharmacologically active agent-containing silicone prepared with powder crystalline forms of the agent, will be extruded through tooling devices as described in (2) using the silicone extrusion machines in (1), to provide a catheter layer within the device that is co-extensive with all or at least some portion of the length of the device.
- the sandwich tubes in (4) above will then be cut into segments of desired lengths and fitted with a tip and a manifold part. The device will then be structurally ready for use.
- the tube containing a sandwiched layer of antimicrobial is in some embodiments to be fitted with a tip made of silicone.
- the tube in (5) is in some embodiments to be then fitted with a silicone manifold, the injection parts being in particular embodiments constructed out of standard plastic manifold materials.
- the tri-layer catheter embodies a design and concept similar to the sandwiched catheter described in Example 1 and the sandwich catheter described above.
- the innermost layer can consist of a single tube (i.e., single lumen) or multi-lumen tube with the limiting circumference preferably composed of silicone.
- the innermost layer can be any medical device or prosthesis requiring antimicrobial coatings to prevent device-related infections.
- Layer 2--Layer 2 is the middle layer of the device, and comprises silicone and any variety of desired pharmacological agent(s).
- the antimicrobial agents are micronized and mixed homogeneously with the "A" and “B” components of the silicone preparation mixtures.
- the silicone mixture "A” and “B” are mixed together at extrusion, thus initiating the catalytic process that cures the silicone and solidifies the device structure.
- This form of mixing of the antimicrobials with equal concentration in A and in B components of the silicone renders a final product with uniform essentially equal concentrations of components A and B. This produces an accurate concentration of antimicrobial per gram silicone.
- a relatively high concentration of antimicrobial agents for use in the invention is about 180 milligrams of antimicrobial/gram of silicone after extrusion. This concentration, of course, will vary from 75%, 50% or even 25%. The selection of particular amounts of the antimicrobial or other active agent in the device will depend upon the design of the catheter or device and its particular intended use.
- Layer 3--Layer 3 in some embodiments of the catheter constitutes the outer-most layer or sheath encapsulating the antimicrobial layer described above.
- this third layer is constructed of silicone.
- the thickness and the formulary type of silicone used to establish its density will determine in some embodiments the rate at which the antimicrobial agents in layer 2 diffuse out and around the circumference of the catheter or device.
- the variations in thickness and density of the silicone used for this layer are a matter of design choice, and will depend upon the intended use of the catheter or device.
- Layers 1, 2, and 3 as described above are extruded simultaneously so as to form a single, solid integral unit with 3 inseparable layers.
- the second layer containing the antimicrobial agents or other pharmacological agents will occupy space and thus tend to increase the relative diameter of the catheter, and/or size of the device. Control of the overall diameter of the device is thus important to consider in particular intended applications for the device, such as for use as vascular catheters where smaller total diameters are desired.
- the solid integration of the second layer also adds support and strength to the walls of the catheter or device, thus permitting one to minimize the thicknesses of layers 1 and 3 to compensate for the added strength and thickness of layer 2. This also enables a reduction of the thicknesses of the whole catheter wall so as to produce a catheter that is sufficiently similar in size so as to provide a device comparable to standard devices/catheters that lack the second and third layers, enhancing the ready usability of the presently disclosed devices.
- the extruded tube composed of the trilayer catheter is to be cut at specific lengths and fitted with other standard catheter components, readily available, to form a useable unit, as already discussed.
- FIG. 12 shows that the antimicrobial agents released from the catheter when present prevented recolonization of the zone of inhibition for up to 90+ days.
- the catheters were constructed as described in Example 1, prototype 2 (as shown in FIG. 2).
- Antimicrobial catheters were prepared as demonstrated in the prototype of Example 1, prototype 2 (FIG. 2) using minocycline/rifampin (2:1) as the antimicrobial agents.
- the samples were embedded in agar plates inoculated with SE-5667 as outlined in Table 1.
- the samples were reimplanted weekly.
- the silicone sheathed antimicrobial device maintained a significant antimicrobial activity, even though challenged repeatedly with reimplantation for 14 consecutive cycles.
- the residual antibiotic inhibitory activity of the 14 consecutive cycles persisted for at least 90 days after catheter reimplantation. Seven such residual activities are illustrated in FIG. 12.
- Antimicrobial catheters were prepared as demonstrated in the prototype 2, FIG. 2 using minocycline/rifampin (2:1) as the antimicrobial agents. After sterilizing the samples with ethylene oxide, the catheters were individually submerged in serum, covered and incubated at 37° C. for the specified time as described above. The samples were left incubating in the serum for 3, 7, 14, 28, 42, 56, 90 and 120 days. At each specified time the samples were removed from the serum and embedded in agar plates similar to the procedure outlined in Table 1 (step B).
- the 24 h zones of inhibition were recorded as a measure of the efficacy of the catheters to control microbial growth.
- the results of this study are represented in FIG. 10. The study was carried out to 120 days, at which time the antimicrobial devices continued to demonstrate significant long-term antimicrobial activity. This activity was similar to the beginning baseline value.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Pulmonology (AREA)
- Hematology (AREA)
- Heart & Thoracic Surgery (AREA)
- Anesthesiology (AREA)
- Biophysics (AREA)
- Urology & Nephrology (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Materials For Medical Uses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
TABLE 1 __________________________________________________________________________ DETERMINATION OF THE ZONE OF INHIBITION __________________________________________________________________________ ##STR1## ##STR2## __________________________________________________________________________
Claims (34)
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/465,587 US5820607A (en) | 1995-06-05 | 1995-06-05 | Multipurpose anti-microbial silastic sheath system for the prevention of device-related infections |
EP96921362A EP1015051B1 (en) | 1995-06-05 | 1996-06-05 | A multipurpose anti-microbial silastic sheath system for the prevention of device-related infections |
ES96921362T ES2235189T3 (en) | 1995-06-05 | 1996-06-05 | ANTIMICROBIAL SILASTIC COVER SYSTEM FOR MULTIPLE USE, FOR THE PREVENTION OF INFECTIONS RELATED TO DEVICES. |
CA002223578A CA2223578A1 (en) | 1995-06-05 | 1996-06-05 | A multipurpose anti-microbial sheath system for the prevention of device-related infections |
PCT/US1996/009446 WO1996039215A1 (en) | 1995-06-05 | 1996-06-05 | A multipurpose anti-microbial silastic sheath system for the prevention of device-related infections |
DE69634099T DE69634099T2 (en) | 1995-06-05 | 1996-06-05 | AN ANTIMICROBIAL SILASTIC CASE WITH MULTIPLE APPLICATIONS FOR PREVENTING INFECTIONS THROUGH THE DEVICES USED |
JP9501762A JPH11506685A (en) | 1995-06-05 | 1996-06-05 | Versatile antibacterial silastic sheath system for preventing device-related infections |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/465,587 US5820607A (en) | 1995-06-05 | 1995-06-05 | Multipurpose anti-microbial silastic sheath system for the prevention of device-related infections |
Publications (1)
Publication Number | Publication Date |
---|---|
US5820607A true US5820607A (en) | 1998-10-13 |
Family
ID=23848381
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/465,587 Expired - Fee Related US5820607A (en) | 1995-06-05 | 1995-06-05 | Multipurpose anti-microbial silastic sheath system for the prevention of device-related infections |
Country Status (7)
Country | Link |
---|---|
US (1) | US5820607A (en) |
EP (1) | EP1015051B1 (en) |
JP (1) | JPH11506685A (en) |
CA (1) | CA2223578A1 (en) |
DE (1) | DE69634099T2 (en) |
ES (1) | ES2235189T3 (en) |
WO (1) | WO1996039215A1 (en) |
Cited By (69)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6451003B1 (en) * | 2000-08-16 | 2002-09-17 | Biolink Corporation | Method and apparatus for overcoming infection in a tissue pocket surrounding an implanted device |
US20030078242A1 (en) * | 2001-01-12 | 2003-04-24 | Board Of Regents, The University Of Texas System | Novel antiseptic derivatives with broad spectrum antimicrobial activity for the impregnation of surfaces |
US6579539B2 (en) | 1999-12-22 | 2003-06-17 | C. R. Bard, Inc. | Dual mode antimicrobial compositions |
US6588425B2 (en) | 2000-12-21 | 2003-07-08 | Kimberly-Clark Worldwide, Inc. | Respiratory suction catheter apparatus with antimicrobial chamber |
US6599275B1 (en) * | 1996-06-04 | 2003-07-29 | Cook Incorporated | Implantable medical device |
WO2003082148A1 (en) * | 2002-03-26 | 2003-10-09 | Biosynexus Incorporated | Enzyme disruption of bacterial biofilms |
US20040047763A1 (en) * | 2001-12-05 | 2004-03-11 | Peter Kite | Anti-microbial systems and methods |
US6716200B2 (en) | 2002-01-18 | 2004-04-06 | C.R. Bard, Inc. | Antimicrobial urine collection system and methods of manufacturing the same |
US20040068241A1 (en) * | 1996-06-04 | 2004-04-08 | Fischer Frank J. | Implantable medical device |
US20040072815A1 (en) * | 2002-02-12 | 2004-04-15 | Koppel Gary A. | Antibiotic composition and method |
US6734157B2 (en) | 1999-12-28 | 2004-05-11 | Kimberly-Clark Worldwide, Inc. | Controlled release anti-microbial hard surface wiper |
US20040110841A1 (en) * | 2001-12-05 | 2004-06-10 | Aseptica, Inc. | Antiseptic compositions, methods and systems |
US20040147877A1 (en) * | 2003-01-27 | 2004-07-29 | Heuser Richard R | Catheter introducer system |
US6794318B2 (en) | 1999-12-28 | 2004-09-21 | Kimberly-Clark Worldwide, Inc. | Use-dependent indicator system for absorbent articles |
US20040225264A1 (en) * | 2003-05-08 | 2004-11-11 | George Bourne | Antimicrobially-charged entry port cuff |
US20040243064A1 (en) * | 2003-05-30 | 2004-12-02 | Codman & Shurtleff, Inc. | Percutaneous access device |
US20050013836A1 (en) * | 2003-06-06 | 2005-01-20 | Board Of Regents, The University Of Texas System | Antimicrobial flush solutions |
US20050100580A1 (en) * | 2003-10-14 | 2005-05-12 | Cook Incorporated | Hydrophilic coated medical device |
US20050197634A1 (en) * | 2004-01-20 | 2005-09-08 | Board Of Regents, The University Of Texas System | Methods for coating and impregnating medical devices with antiseptic compositions |
US20050267543A1 (en) * | 2003-03-20 | 2005-12-01 | Medtronic Inc | Antimicrobial protection for implantable medical device |
US20060025726A1 (en) * | 1996-06-04 | 2006-02-02 | Vance Products Incorporated, D/B/A Cook Urological Incorporated | Implantable medical device with pharmacologically active layer |
US20060030826A1 (en) * | 1996-06-04 | 2006-02-09 | Vance Products Incorporated,d/b/a Cook Urological Incorporated | Implantable medical device with anti-neoplastic drug |
US20060039946A1 (en) * | 2004-08-20 | 2006-02-23 | Medtronic Inc. | Drug eluting medical device |
US20060052757A1 (en) * | 1996-06-04 | 2006-03-09 | Vance Products Incorporated, D/B/A Cook Urological Incorporated | Implantable medical device with analgesic or anesthetic |
US20060126751A1 (en) * | 2004-12-10 | 2006-06-15 | Anthony Bessios | Technique for disparity bounding coding in a multi-level signaling system |
US20060142339A1 (en) * | 2003-06-19 | 2006-06-29 | Bosmans Jean-Paul R M | Aminosulfonyl substituted 4-(aminomethyl)-piperidine benzamides as 5ht 4-antagonists |
US20070129690A1 (en) * | 2005-12-02 | 2007-06-07 | Joel Rosenblatt | Catheter with polymeric coating |
US20080033371A1 (en) * | 2006-06-26 | 2008-02-07 | Updegraff Debra K | Cover for catheter assembly |
US20080075628A1 (en) * | 2006-09-27 | 2008-03-27 | Medtronic, Inc. | Sterilized minocycline and rifampin-containing medical device |
US20080125728A1 (en) * | 2006-09-27 | 2008-05-29 | Medtronic, Inc. | Two part antimicrobial boot |
US20080172011A1 (en) * | 2006-09-29 | 2008-07-17 | Tyco Healthcare Group Lp | Catheters including antimicrobial sleeve and methods of making catheters |
US7410665B2 (en) | 1995-06-07 | 2008-08-12 | Cook Incorporated | Coated implantable medical device |
CN100430105C (en) * | 2002-04-01 | 2008-11-05 | Nd合伙人股份有限公司 | Method and device for preventing infection in tissue bag around implantation aapliance |
WO2008132718A2 (en) | 2007-05-01 | 2008-11-06 | Sure International Ventures B.V. | Biocidic medical devices, implants and wound dressings |
US7550005B2 (en) | 1995-06-07 | 2009-06-23 | Cook Incorporated | Coated implantable medical device |
US20090198197A1 (en) * | 2007-04-17 | 2009-08-06 | Medtronic, Inc. | Therapeutic sleeve for implantable medical device |
US7611533B2 (en) | 1995-06-07 | 2009-11-03 | Cook Incorporated | Coated implantable medical device |
US20100082097A1 (en) * | 2008-10-01 | 2010-04-01 | Joel Rosenblatt | Article Containing Segregated Biguanide and Lewis Acid |
US7731685B2 (en) | 2002-07-12 | 2010-06-08 | Cook Incorporated | Coated medical device |
US7750041B2 (en) | 2001-03-26 | 2010-07-06 | Bayer Schering Pharma Aktiengesellschaft | Preparation for the prophylaxis of restenosis |
US20100221237A1 (en) * | 2003-03-26 | 2010-09-02 | Biosynexus Incorporated | Enzyme disruption of bacterial biofilms |
US7846202B2 (en) | 1995-06-07 | 2010-12-07 | Cook Incorporated | Coated implantable medical device |
US7867275B2 (en) | 1995-06-07 | 2011-01-11 | Cook Incorporated | Coated implantable medical device method |
US7896914B2 (en) | 1995-06-07 | 2011-03-01 | Cook Incorporated | Coated implantable medical device |
US20110066141A1 (en) * | 2009-09-11 | 2011-03-17 | Cook Incorporated | Implantable medical device having an anti-gastric distress agent |
US20110071478A1 (en) * | 2009-09-09 | 2011-03-24 | Jian-Lin Liu | Methods of manufacturing drug-loaded substrates |
US20110091669A1 (en) * | 2009-10-20 | 2011-04-21 | The Hong Kong Polytechnic University | Method for fabrication of silicone composite with antimicrobial coating |
US20110106014A1 (en) * | 2009-10-29 | 2011-05-05 | Helm Jr Robert E | Sealed sterile catheter dressings |
US7947301B2 (en) | 2007-04-17 | 2011-05-24 | Medtronic, Inc. | Reduction of infection associated with medical device |
US20110152791A1 (en) * | 2008-08-11 | 2011-06-23 | Terumo Kabushiki Kaisha | Medical instrument |
US8062321B2 (en) | 2006-01-25 | 2011-11-22 | Pq Bypass, Inc. | Catheter system for connecting adjacent blood vessels |
US8257305B2 (en) | 2002-09-20 | 2012-09-04 | Bayer Pharma Aktiengesellschaft | Medical device for dispensing medicaments |
US8545418B2 (en) | 2004-08-25 | 2013-10-01 | Richard R. Heuser | Systems and methods for ablation of occlusions within blood vessels |
WO2013158927A1 (en) | 2012-04-18 | 2013-10-24 | Saint-Gobain Performance Plastics Corporation | Silicone tubing and method for making and using same |
US8715242B2 (en) | 2011-01-31 | 2014-05-06 | Robert E. HELM, JR. | Snap-seal sterile intravascular catheter-dressing system |
US8864730B2 (en) | 2005-04-12 | 2014-10-21 | Rochester Medical Corporation | Silicone rubber male external catheter with absorbent and adhesive |
US9078712B2 (en) | 2009-04-15 | 2015-07-14 | Warsaw Orthopedic, Inc. | Preformed drug-eluting device to be affixed to an anterior spinal plate |
WO2016181397A1 (en) * | 2015-05-13 | 2016-11-17 | Innoventions Ltd. | System for inhibiting biofilm formation on catheters, other indwelling or implantable devices and other devices |
US20170043119A1 (en) * | 2015-08-10 | 2017-02-16 | Asahi Intecc Co., Ltd. | Catheter and balloon catheter |
US9707375B2 (en) | 2011-03-14 | 2017-07-18 | Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. | Catheter grip and method |
US9872969B2 (en) | 2012-11-20 | 2018-01-23 | Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. | Catheter in bag without additional packaging |
US10092728B2 (en) | 2012-11-20 | 2018-10-09 | Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. | Sheath for securing urinary catheter |
US10149956B2 (en) | 2015-02-28 | 2018-12-11 | John P. Ure | Bi-lateral endobronchial suctioning device and medical suctioning system for intubated patients |
US10589003B2 (en) | 2005-11-18 | 2020-03-17 | The Board Of Regents Of The University Of Texas System | Methods for coating surfaces with antimicrobial agents |
US10625049B2 (en) | 2010-09-09 | 2020-04-21 | W. L. Gore & Associates, Inc. | Indwelling luminal devices |
US10682507B2 (en) | 2009-10-29 | 2020-06-16 | One Iv Solutions, Llc | Catheter extension with integrated circumferentially sealing securement dressing |
US10857324B2 (en) | 2014-08-26 | 2020-12-08 | C. R. Bard, Inc. | Urinary catheter |
USD930831S1 (en) | 2020-03-05 | 2021-09-14 | Jim Benton | Microbial barrier tubing clamp |
US11547599B2 (en) | 2017-09-19 | 2023-01-10 | C. R. Bard, Inc. | Urinary catheter bridging device, systems and methods thereof |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2000074743A1 (en) * | 1999-06-04 | 2000-12-14 | Oxibio, Inc. | Anti-infective medical device and production method |
US8092443B2 (en) | 2009-03-30 | 2012-01-10 | Medtronic, Inc. | Element for implantation with medical device |
US20100278895A1 (en) | 2009-04-30 | 2010-11-04 | Medtronic, Inc. | Antioxidants and antimicrobial accessories including antioxidants |
US8262619B2 (en) * | 2010-09-30 | 2012-09-11 | Tyco Healthcare Group Lp | Introducer sheath for catheters |
US8911427B2 (en) | 2010-12-28 | 2014-12-16 | Medtronic, Inc. | Therapeutic agent reservoir delivery system |
WO2017134049A1 (en) | 2016-02-01 | 2017-08-10 | Schierholz Jörg Michael | Implantable medical products, a process for the preparation thereof, and use thereof |
Citations (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3566874A (en) * | 1968-08-13 | 1971-03-02 | Nat Patent Dev Corp | Catheter |
US3598127A (en) * | 1968-06-06 | 1971-08-10 | James G Wepsic | Catheter having antibacterial substance therein provided with means permitting slow release of said substance |
US4623329A (en) * | 1983-12-15 | 1986-11-18 | The Procter & Gamble Company | Drainage and infusion catheters having a capillary sleeve forming a reservoir for a fluid antimicrobial agent |
US4677143A (en) * | 1984-10-01 | 1987-06-30 | Baxter Travenol Laboratories, Inc. | Antimicrobial compositions |
US4925668A (en) * | 1989-01-18 | 1990-05-15 | Becton, Dickinson And Company | Anti-infective and lubricious medical articles and method for their preparation |
US4994047A (en) * | 1988-05-06 | 1991-02-19 | Menlo Care, Inc. | Multi-layer cannula structure |
US4999210A (en) * | 1989-01-18 | 1991-03-12 | Becton, Dickinson And Company | Anti-infective and antithrombogenic medical articles and method for their preparation |
WO1991010466A1 (en) * | 1990-01-10 | 1991-07-25 | Rochester Medical Corporation | Microcidal agent releasing catheter |
US5041100A (en) * | 1989-04-28 | 1991-08-20 | Cordis Corporation | Catheter and hydrophilic, friction-reducing coating thereon |
EP0467516A1 (en) * | 1990-07-20 | 1992-01-22 | Cabot Technology Corporation | Hemostatic stent |
US5217493A (en) * | 1992-03-11 | 1993-06-08 | Board Of Regents, The University Of Texas System | Antibacterial coated medical implants |
US5324275A (en) * | 1992-10-02 | 1994-06-28 | Board Of Regeants, University Of Texas System | Antimicrobial medical devices |
US5362754A (en) * | 1992-11-12 | 1994-11-08 | Univ. Of Tx Md Anderson Cancer Center | M-EDTA pharmaceutical preparations and uses thereof |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1995010989A1 (en) * | 1993-10-19 | 1995-04-27 | Scimed Life Systems, Inc. | Intravascular stent pump |
-
1995
- 1995-06-05 US US08/465,587 patent/US5820607A/en not_active Expired - Fee Related
-
1996
- 1996-06-05 WO PCT/US1996/009446 patent/WO1996039215A1/en active IP Right Grant
- 1996-06-05 ES ES96921362T patent/ES2235189T3/en not_active Expired - Lifetime
- 1996-06-05 JP JP9501762A patent/JPH11506685A/en not_active Ceased
- 1996-06-05 CA CA002223578A patent/CA2223578A1/en not_active Abandoned
- 1996-06-05 EP EP96921362A patent/EP1015051B1/en not_active Expired - Lifetime
- 1996-06-05 DE DE69634099T patent/DE69634099T2/en not_active Expired - Fee Related
Patent Citations (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3598127A (en) * | 1968-06-06 | 1971-08-10 | James G Wepsic | Catheter having antibacterial substance therein provided with means permitting slow release of said substance |
US3566874A (en) * | 1968-08-13 | 1971-03-02 | Nat Patent Dev Corp | Catheter |
US4623329A (en) * | 1983-12-15 | 1986-11-18 | The Procter & Gamble Company | Drainage and infusion catheters having a capillary sleeve forming a reservoir for a fluid antimicrobial agent |
US4677143A (en) * | 1984-10-01 | 1987-06-30 | Baxter Travenol Laboratories, Inc. | Antimicrobial compositions |
US4994047A (en) * | 1988-05-06 | 1991-02-19 | Menlo Care, Inc. | Multi-layer cannula structure |
US4999210A (en) * | 1989-01-18 | 1991-03-12 | Becton, Dickinson And Company | Anti-infective and antithrombogenic medical articles and method for their preparation |
US4925668A (en) * | 1989-01-18 | 1990-05-15 | Becton, Dickinson And Company | Anti-infective and lubricious medical articles and method for their preparation |
US5041100A (en) * | 1989-04-28 | 1991-08-20 | Cordis Corporation | Catheter and hydrophilic, friction-reducing coating thereon |
WO1991010466A1 (en) * | 1990-01-10 | 1991-07-25 | Rochester Medical Corporation | Microcidal agent releasing catheter |
EP0467516A1 (en) * | 1990-07-20 | 1992-01-22 | Cabot Technology Corporation | Hemostatic stent |
US5217493A (en) * | 1992-03-11 | 1993-06-08 | Board Of Regents, The University Of Texas System | Antibacterial coated medical implants |
US5324275A (en) * | 1992-10-02 | 1994-06-28 | Board Of Regeants, University Of Texas System | Antimicrobial medical devices |
US5362754A (en) * | 1992-11-12 | 1994-11-08 | Univ. Of Tx Md Anderson Cancer Center | M-EDTA pharmaceutical preparations and uses thereof |
Non-Patent Citations (8)
Title |
---|
Durand et al., "Characterization of Antigen Receptor Response Elements within the Interleukin-2 Enhancer," Molecular and Cellular Biology, 8(2):1715-1724, Apr. 1988. |
Durand et al., Characterization of Antigen Receptor Response Elements within the Interleukin 2 Enhancer, Molecular and Cellular Biology , 8(2):1715 1724, Apr. 1988. * |
Owaki et al., "Raf-1 is Required for T Cell IL2 Production," The EMBO Journal, 12(11):4367-4373, 1993. |
Owaki et al., Raf 1 is Required for T Cell IL2 Production, The EMBO Journal , 12(11):4367 4373, 1993. * |
Schierholz et al., "In Vitro Efficacy of an Antibiotic Releasing Silicone Ventricle Catheter to Prevent Shunt Infection," Biomaterial, 15(12):996-1000, Oct. 1994. |
Schierholz et al., In Vitro Efficacy of an Antibiotic Releasing Silicone Ventricle Catheter to Prevent Shunt Infection, Biomaterial , 15(12):996 1000, Oct. 1994. * |
Sheretz et al., "Efficacy of Antibiotic-Coated Catheters in Preventing Subcutaneous Staphylococcus aureus Infection in Rabbits," The Journal of Infectious Diseases, 167:98-106, 1993. |
Sheretz et al., Efficacy of Antibiotic Coated Catheters in Preventing Subcutaneous Staphylococcus aureus Infection in Rabbits, The Journal of Infectious Diseases , 167:98 106, 1993. * |
Cited By (136)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7550005B2 (en) | 1995-06-07 | 2009-06-23 | Cook Incorporated | Coated implantable medical device |
US8945206B2 (en) | 1995-06-07 | 2015-02-03 | Cook Medical Technologies Llc | Methods for making implantable medical devices |
US8257433B2 (en) | 1995-06-07 | 2012-09-04 | Cook Medical Technologies Llc | Coated implantable medical device |
US7811622B2 (en) | 1995-06-07 | 2010-10-12 | Cook Incorporated | Coated implantable medical device |
US8758428B2 (en) | 1995-06-07 | 2014-06-24 | Cook Medical Technologies Llc | Coated implantable medical device |
US7846202B2 (en) | 1995-06-07 | 2010-12-07 | Cook Incorporated | Coated implantable medical device |
US7862605B2 (en) | 1995-06-07 | 2011-01-04 | Med Institute, Inc. | Coated implantable medical device |
US7896914B2 (en) | 1995-06-07 | 2011-03-01 | Cook Incorporated | Coated implantable medical device |
US7611533B2 (en) | 1995-06-07 | 2009-11-03 | Cook Incorporated | Coated implantable medical device |
US7901453B2 (en) | 1995-06-07 | 2011-03-08 | Cook Incorporated | Coated implantable medical device |
US7867275B2 (en) | 1995-06-07 | 2011-01-11 | Cook Incorporated | Coated implantable medical device method |
US8469943B2 (en) | 1995-06-07 | 2013-06-25 | Cook Medical Technologies Llc | Coated implantable medical device |
US7410665B2 (en) | 1995-06-07 | 2008-08-12 | Cook Incorporated | Coated implantable medical device |
US7799070B2 (en) | 1995-06-07 | 2010-09-21 | Cook Incorporated | Coated implantable medical device |
US7611532B2 (en) | 1995-06-07 | 2009-11-03 | Cook Incorporated | Coated implantable medical device |
US8556962B2 (en) | 1995-06-07 | 2013-10-15 | Cook Medical Technologies Llc | Coated implantable medical device |
US6599275B1 (en) * | 1996-06-04 | 2003-07-29 | Cook Incorporated | Implantable medical device |
US20040068241A1 (en) * | 1996-06-04 | 2004-04-08 | Fischer Frank J. | Implantable medical device |
US20060030826A1 (en) * | 1996-06-04 | 2006-02-09 | Vance Products Incorporated,d/b/a Cook Urological Incorporated | Implantable medical device with anti-neoplastic drug |
US20060052757A1 (en) * | 1996-06-04 | 2006-03-09 | Vance Products Incorporated, D/B/A Cook Urological Incorporated | Implantable medical device with analgesic or anesthetic |
US20060025726A1 (en) * | 1996-06-04 | 2006-02-02 | Vance Products Incorporated, D/B/A Cook Urological Incorporated | Implantable medical device with pharmacologically active layer |
US6579539B2 (en) | 1999-12-22 | 2003-06-17 | C. R. Bard, Inc. | Dual mode antimicrobial compositions |
US6734157B2 (en) | 1999-12-28 | 2004-05-11 | Kimberly-Clark Worldwide, Inc. | Controlled release anti-microbial hard surface wiper |
US6794318B2 (en) | 1999-12-28 | 2004-09-21 | Kimberly-Clark Worldwide, Inc. | Use-dependent indicator system for absorbent articles |
US6451003B1 (en) * | 2000-08-16 | 2002-09-17 | Biolink Corporation | Method and apparatus for overcoming infection in a tissue pocket surrounding an implanted device |
US8172793B2 (en) | 2000-10-31 | 2012-05-08 | Cook Medical Technologies Llc | Coated medical device |
US8673387B2 (en) | 2000-10-31 | 2014-03-18 | Cook Medical Technologies Llc | Coated medical device |
US9814865B2 (en) | 2000-10-31 | 2017-11-14 | Cook Medical Technologies Llc | Coated medical device |
US8974522B2 (en) | 2000-10-31 | 2015-03-10 | Cook Medical Technologies Llc | Coated medical device |
US9694162B2 (en) | 2000-10-31 | 2017-07-04 | Cook Medical Technologies Llc | Coated medical device |
US6588425B2 (en) | 2000-12-21 | 2003-07-08 | Kimberly-Clark Worldwide, Inc. | Respiratory suction catheter apparatus with antimicrobial chamber |
US7651661B2 (en) | 2001-01-12 | 2010-01-26 | Board Of Regents, The University Of Texas System | Medical devices with broad spectrum antimicrobial activity |
US20030078242A1 (en) * | 2001-01-12 | 2003-04-24 | Board Of Regents, The University Of Texas System | Novel antiseptic derivatives with broad spectrum antimicrobial activity for the impregnation of surfaces |
US20080183152A1 (en) * | 2001-01-12 | 2008-07-31 | Issam Raad | Medical devices with broad spectrum antimicrobial activity |
US7713472B2 (en) | 2001-01-12 | 2010-05-11 | Board Of Regents, The University Of Texas System | Antiseptic derivatives with broad spectrum antimicrobial activity for the impregnation of surfaces |
US8389043B2 (en) | 2001-03-26 | 2013-03-05 | Bayer Pharma Aktiengesellschaft | Preparation for restenosis prevention |
US9066990B2 (en) | 2001-03-26 | 2015-06-30 | Bayer Intellectual Property Gmbh | Preparation for restenosis prevention |
US7750041B2 (en) | 2001-03-26 | 2010-07-06 | Bayer Schering Pharma Aktiengesellschaft | Preparation for the prophylaxis of restenosis |
US20040047763A1 (en) * | 2001-12-05 | 2004-03-11 | Peter Kite | Anti-microbial systems and methods |
US8541472B2 (en) | 2001-12-05 | 2013-09-24 | Aseptica, Inc. | Antiseptic compositions, methods and systems |
US20040110841A1 (en) * | 2001-12-05 | 2004-06-10 | Aseptica, Inc. | Antiseptic compositions, methods and systems |
US6716200B2 (en) | 2002-01-18 | 2004-04-06 | C.R. Bard, Inc. | Antimicrobial urine collection system and methods of manufacturing the same |
US20040072815A1 (en) * | 2002-02-12 | 2004-04-15 | Koppel Gary A. | Antibiotic composition and method |
US20030215433A1 (en) * | 2002-03-26 | 2003-11-20 | Biosynexus, Inc. | Enzyme disruption of bacterial biofilms |
EP1494614A4 (en) * | 2002-03-26 | 2010-08-11 | Biosynexus Inc | Enzyme disruption of bacterial biofilms |
EP1494614A1 (en) * | 2002-03-26 | 2005-01-12 | Biosynexus Incorporated | Enzyme disruption of bacterial biofilms |
US7572439B2 (en) | 2002-03-26 | 2009-08-11 | Biosynexus Incorporated | Enzyme disruption of bacterial biofilms |
WO2003082148A1 (en) * | 2002-03-26 | 2003-10-09 | Biosynexus Incorporated | Enzyme disruption of bacterial biofilms |
CN100430105C (en) * | 2002-04-01 | 2008-11-05 | Nd合伙人股份有限公司 | Method and device for preventing infection in tissue bag around implantation aapliance |
CN101461982B (en) * | 2002-04-01 | 2012-06-27 | Nd合伙人股份有限公司 | Device for overcoming infection contamination in tissue bag surrounding implantation instrument |
US10532190B2 (en) | 2002-07-12 | 2020-01-14 | Cook Medical Technologies Llc | Coated medical device |
US7731685B2 (en) | 2002-07-12 | 2010-06-08 | Cook Incorporated | Coated medical device |
US7803149B2 (en) | 2002-07-12 | 2010-09-28 | Cook Incorporated | Coated medical device |
US8439868B2 (en) | 2002-09-20 | 2013-05-14 | Bayer Pharma AG | Medical device for dispersing medicaments |
US9649476B2 (en) | 2002-09-20 | 2017-05-16 | Bayer Intellectual Property Gmbh | Medical device for dispersing medicaments |
US8257305B2 (en) | 2002-09-20 | 2012-09-04 | Bayer Pharma Aktiengesellschaft | Medical device for dispensing medicaments |
US7914492B2 (en) | 2003-01-27 | 2011-03-29 | Heuser Richard R | Catheter introducer system |
US20040147877A1 (en) * | 2003-01-27 | 2004-07-29 | Heuser Richard R | Catheter introducer system |
US7166088B2 (en) | 2003-01-27 | 2007-01-23 | Heuser Richard R | Catheter introducer system |
US20050267543A1 (en) * | 2003-03-20 | 2005-12-01 | Medtronic Inc | Antimicrobial protection for implantable medical device |
US20100221237A1 (en) * | 2003-03-26 | 2010-09-02 | Biosynexus Incorporated | Enzyme disruption of bacterial biofilms |
US7947021B2 (en) | 2003-05-08 | 2011-05-24 | Boston Scientific Scimed, Inc. | Antimicrobially-charged entry port cuff |
US20040225264A1 (en) * | 2003-05-08 | 2004-11-11 | George Bourne | Antimicrobially-charged entry port cuff |
US6916310B2 (en) | 2003-05-30 | 2005-07-12 | Codman & Shurtleff, Inc. | Percutaneous access device |
US20050203486A1 (en) * | 2003-05-30 | 2005-09-15 | Bob Sommerich | Percutaneous access device |
US7331940B2 (en) | 2003-05-30 | 2008-02-19 | Codman & Shurtleff, Inc. | Percutaneous access device |
US20040243064A1 (en) * | 2003-05-30 | 2004-12-02 | Codman & Shurtleff, Inc. | Percutaneous access device |
US8709342B2 (en) | 2003-06-06 | 2014-04-29 | Board Of Regents, The University Of Texas System | Antimicrobial flush solutions |
US20100055086A1 (en) * | 2003-06-06 | 2010-03-04 | Issam Raad | Antimicrobial Flush Solutions |
US20050013836A1 (en) * | 2003-06-06 | 2005-01-20 | Board Of Regents, The University Of Texas System | Antimicrobial flush solutions |
US9078441B2 (en) | 2003-06-06 | 2015-07-14 | Board Of Regents, The University Of Texas System | Antimicrobial flush solutions |
US20110201692A1 (en) * | 2003-06-06 | 2011-08-18 | The Board Of Regents Of The University Of Texas System | Antimicrobial flush solutions |
US7601731B2 (en) | 2003-06-06 | 2009-10-13 | Board Of Regents, The University Of Texas System | Antimicrobial flush solutions |
US20060142339A1 (en) * | 2003-06-19 | 2006-06-29 | Bosmans Jean-Paul R M | Aminosulfonyl substituted 4-(aminomethyl)-piperidine benzamides as 5ht 4-antagonists |
US20050100580A1 (en) * | 2003-10-14 | 2005-05-12 | Cook Incorporated | Hydrophilic coated medical device |
US20050197634A1 (en) * | 2004-01-20 | 2005-09-08 | Board Of Regents, The University Of Texas System | Methods for coating and impregnating medical devices with antiseptic compositions |
US20060039946A1 (en) * | 2004-08-20 | 2006-02-23 | Medtronic Inc. | Drug eluting medical device |
US8545418B2 (en) | 2004-08-25 | 2013-10-01 | Richard R. Heuser | Systems and methods for ablation of occlusions within blood vessels |
US20060126751A1 (en) * | 2004-12-10 | 2006-06-15 | Anthony Bessios | Technique for disparity bounding coding in a multi-level signaling system |
US8864730B2 (en) | 2005-04-12 | 2014-10-21 | Rochester Medical Corporation | Silicone rubber male external catheter with absorbent and adhesive |
US9248058B2 (en) | 2005-04-12 | 2016-02-02 | Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. | Male external catheter with absorbent and adhesive |
US10589003B2 (en) | 2005-11-18 | 2020-03-17 | The Board Of Regents Of The University Of Texas System | Methods for coating surfaces with antimicrobial agents |
US20070129690A1 (en) * | 2005-12-02 | 2007-06-07 | Joel Rosenblatt | Catheter with polymeric coating |
US8062321B2 (en) | 2006-01-25 | 2011-11-22 | Pq Bypass, Inc. | Catheter system for connecting adjacent blood vessels |
US20080033371A1 (en) * | 2006-06-26 | 2008-02-07 | Updegraff Debra K | Cover for catheter assembly |
US8298564B2 (en) | 2006-09-27 | 2012-10-30 | Medtronic, Inc. | Two part antimicrobial boot |
US20080125728A1 (en) * | 2006-09-27 | 2008-05-29 | Medtronic, Inc. | Two part antimicrobial boot |
US20080075628A1 (en) * | 2006-09-27 | 2008-03-27 | Medtronic, Inc. | Sterilized minocycline and rifampin-containing medical device |
US20080172011A1 (en) * | 2006-09-29 | 2008-07-17 | Tyco Healthcare Group Lp | Catheters including antimicrobial sleeve and methods of making catheters |
US10188826B2 (en) | 2006-09-29 | 2019-01-29 | Covidien Lp | Catheters including antimicrobial sleeve and methods of making catheters |
US7947301B2 (en) | 2007-04-17 | 2011-05-24 | Medtronic, Inc. | Reduction of infection associated with medical device |
US20110189256A1 (en) * | 2007-04-17 | 2011-08-04 | Medtronic, Inc. | Reduction of infection associated with medical device |
US20090198197A1 (en) * | 2007-04-17 | 2009-08-06 | Medtronic, Inc. | Therapeutic sleeve for implantable medical device |
US8337877B2 (en) | 2007-04-17 | 2012-12-25 | Medtronic, Inc. | Reduction of infection associated with medical device |
US8430852B2 (en) | 2007-04-17 | 2013-04-30 | Medtronic, Inc. | Therapeutic sleeve for implantable medical device |
WO2008132718A2 (en) | 2007-05-01 | 2008-11-06 | Sure International Ventures B.V. | Biocidic medical devices, implants and wound dressings |
US20110152791A1 (en) * | 2008-08-11 | 2011-06-23 | Terumo Kabushiki Kaisha | Medical instrument |
US9180278B2 (en) * | 2008-08-11 | 2015-11-10 | Terumo Kabushiki Kaisha | Medical instrument |
US20100082097A1 (en) * | 2008-10-01 | 2010-04-01 | Joel Rosenblatt | Article Containing Segregated Biguanide and Lewis Acid |
US9078712B2 (en) | 2009-04-15 | 2015-07-14 | Warsaw Orthopedic, Inc. | Preformed drug-eluting device to be affixed to an anterior spinal plate |
US9216268B2 (en) | 2009-09-09 | 2015-12-22 | Cook Medical Technologies Llc | Methods of manufacturing drug-loaded substrates |
US8673388B2 (en) | 2009-09-09 | 2014-03-18 | Cook Medical Technologies Llc | Methods of manufacturing drug-loaded substrates |
US20110071478A1 (en) * | 2009-09-09 | 2011-03-24 | Jian-Lin Liu | Methods of manufacturing drug-loaded substrates |
US20110066141A1 (en) * | 2009-09-11 | 2011-03-17 | Cook Incorporated | Implantable medical device having an anti-gastric distress agent |
US8133423B2 (en) * | 2009-10-20 | 2012-03-13 | The Hong Kong Polytechnic University | Method for fabrication of silicone composite with antimicrobial coating |
US20110091669A1 (en) * | 2009-10-20 | 2011-04-21 | The Hong Kong Polytechnic University | Method for fabrication of silicone composite with antimicrobial coating |
US11969570B2 (en) | 2009-10-29 | 2024-04-30 | One Iv Solutions, Llc | Catheter extension with integrated circumferentially sealing securement dressing |
US9808601B2 (en) * | 2009-10-29 | 2017-11-07 | Robert E. HELM, JR. | Sealed sterile catheter dressings |
US10682507B2 (en) | 2009-10-29 | 2020-06-16 | One Iv Solutions, Llc | Catheter extension with integrated circumferentially sealing securement dressing |
US20110106014A1 (en) * | 2009-10-29 | 2011-05-05 | Helm Jr Robert E | Sealed sterile catheter dressings |
US11571544B2 (en) | 2010-09-09 | 2023-02-07 | W. L. Gore & Associates, Inc. | Indwelling luminal devices |
US10625049B2 (en) | 2010-09-09 | 2020-04-21 | W. L. Gore & Associates, Inc. | Indwelling luminal devices |
US8715242B2 (en) | 2011-01-31 | 2014-05-06 | Robert E. HELM, JR. | Snap-seal sterile intravascular catheter-dressing system |
US11607524B2 (en) | 2011-03-14 | 2023-03-21 | Rochester Medical Corporation | Catheter grip and method |
US9707375B2 (en) | 2011-03-14 | 2017-07-18 | Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. | Catheter grip and method |
US10569051B2 (en) | 2011-03-14 | 2020-02-25 | Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. | Catheter grip and method |
US9533134B2 (en) | 2012-04-18 | 2017-01-03 | Saint-Gobain Performance Plastics Corporation | Silicone tubing and method for making and using same |
WO2013158927A1 (en) | 2012-04-18 | 2013-10-24 | Saint-Gobain Performance Plastics Corporation | Silicone tubing and method for making and using same |
US10780244B2 (en) | 2012-11-20 | 2020-09-22 | Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. | Catheter in a bag without additional packaging |
US10092728B2 (en) | 2012-11-20 | 2018-10-09 | Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. | Sheath for securing urinary catheter |
US11730919B2 (en) | 2012-11-20 | 2023-08-22 | Rochester Medical Corporation | Catheter in bag without additional packaging |
US9872969B2 (en) | 2012-11-20 | 2018-01-23 | Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. | Catheter in bag without additional packaging |
US10874825B2 (en) | 2014-08-26 | 2020-12-29 | C. R. Bard, Inc. | Urinary catheter |
US11850370B2 (en) | 2014-08-26 | 2023-12-26 | C. R. Bard, Inc. | Urinary catheter |
US10857324B2 (en) | 2014-08-26 | 2020-12-08 | C. R. Bard, Inc. | Urinary catheter |
US10149956B2 (en) | 2015-02-28 | 2018-12-11 | John P. Ure | Bi-lateral endobronchial suctioning device and medical suctioning system for intubated patients |
US11083868B2 (en) * | 2015-05-13 | 2021-08-10 | Innoventions Ltd. | System for inhibiting biofilm formation on catheters, other indwelling or implantable devices and other devices |
CN107847711A (en) * | 2015-05-13 | 2018-03-27 | 英诺威讯有限公司 | For suppressing the system of biofilm formation on conduit, other indwellings or implanted device and other devices |
US20180117279A1 (en) * | 2015-05-13 | 2018-05-03 | Innoventions Ltd. | System for inhibiting biofilm formation on catheters, other indwelling or implantable devices and other devices |
AU2016261710B2 (en) * | 2015-05-13 | 2020-05-07 | Innoventions Ltd. | System for inhibiting biofilm formation on catheters, other indwelling or implantable devices and other devices |
WO2016181397A1 (en) * | 2015-05-13 | 2016-11-17 | Innoventions Ltd. | System for inhibiting biofilm formation on catheters, other indwelling or implantable devices and other devices |
US20170043119A1 (en) * | 2015-08-10 | 2017-02-16 | Asahi Intecc Co., Ltd. | Catheter and balloon catheter |
US11633567B2 (en) | 2015-08-10 | 2023-04-25 | Asahi Intecc Co., Ltd. | Catheter and balloon catheter |
US10653858B2 (en) * | 2015-08-10 | 2020-05-19 | Asahi Intecc Co., Ltd. | Catheter and balloon catheter |
US11547599B2 (en) | 2017-09-19 | 2023-01-10 | C. R. Bard, Inc. | Urinary catheter bridging device, systems and methods thereof |
USD930831S1 (en) | 2020-03-05 | 2021-09-14 | Jim Benton | Microbial barrier tubing clamp |
Also Published As
Publication number | Publication date |
---|---|
EP1015051A4 (en) | 2000-07-05 |
CA2223578A1 (en) | 1996-12-12 |
ES2235189T3 (en) | 2005-07-01 |
EP1015051A1 (en) | 2000-07-05 |
DE69634099D1 (en) | 2005-01-27 |
EP1015051B1 (en) | 2004-12-22 |
DE69634099T2 (en) | 2006-03-02 |
JPH11506685A (en) | 1999-06-15 |
WO1996039215A1 (en) | 1996-12-12 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US5820607A (en) | Multipurpose anti-microbial silastic sheath system for the prevention of device-related infections | |
US5707366A (en) | Anti-infective and antithrombogenic medical articles and method for their preparation | |
US4999210A (en) | Anti-infective and antithrombogenic medical articles and method for their preparation | |
US5013306A (en) | Anti-infective and antithrombogenic medical articles and method for their preparation | |
EP0379269B1 (en) | Anti-infection and antithrombogenic medical articles and method for their preparation | |
US6261271B1 (en) | Anti-infective and antithrombogenic medical articles and method for their preparation | |
EP0615458B1 (en) | Method of reducing medical device related infections | |
EP0379271B1 (en) | Anti-infective and lubricious medical articles and method for their preparation | |
Bayston et al. | Prevention of hydrocephalus shunt catheter colonisation in vitro by impregnation with antimicrobials. | |
Schierholz et al. | The antimicrobial efficacy of a new central venous catheter with long-term broad-spectrum activity | |
US20170354813A1 (en) | Medical devices and methods of making medical devices | |
US10022476B2 (en) | Drug releasing medical catheters, tubes, and devices | |
JP2003527209A (en) | Matrix containing nitric oxide donor and reducing agent and use thereof | |
US7597903B2 (en) | Method and composition for producing catheters with antibacterial property | |
Wilcox et al. | Binding of teicoplanin and vancomycin to polymer surfaces | |
ES2951010T3 (en) | Implantable health products, procedure for their preparation and use thereof | |
Gilmore et al. | Antimicrobial devices |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: BOARD OF REGENTS, THE UNIVERSITY OF TEXAS SYSTEM, Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:TCHOLAKIAN, ROBERT;RAAD, ISSAM;REEL/FRAME:007567/0172 Effective date: 19950804 |
|
CC | Certificate of correction | ||
AS | Assignment |
Owner name: COOK INCORPORATED, INDIANA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BOARD OF REGENTS, UNIVERSITY OF TEXAS SYSTEM, THE;REEL/FRAME:010742/0761 Effective date: 20000413 |
|
FEPP | Fee payment procedure |
Free format text: PAT HOLDER NO LONGER CLAIMS SMALL ENTITY STATUS, ENTITY STATUS SET TO UNDISCOUNTED (ORIGINAL EVENT CODE: STOL); ENTITY STATUS OF PATENT OWNER: LARGE ENTITY |
|
REFU | Refund |
Free format text: REFUND - PAYMENT OF MAINTENANCE FEE, 4TH YR, SMALL ENTITY (ORIGINAL EVENT CODE: R283); ENTITY STATUS OF PATENT OWNER: LARGE ENTITY |
|
FPAY | Fee payment |
Year of fee payment: 4 |
|
AS | Assignment |
Owner name: BOARD OF REGENTS THE UNIVERSITY OF TEXAS SYSTEM, T Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:COOK INCORPORATED;REEL/FRAME:016722/0547 Effective date: 20050623 |
|
AS | Assignment |
Owner name: BOARD OF REGENTS, TEXAS Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:COOK INCORPORATED;REEL/FRAME:016914/0171 Effective date: 20050822 |
|
FPAY | Fee payment |
Year of fee payment: 8 |
|
REMI | Maintenance fee reminder mailed | ||
LAPS | Lapse for failure to pay maintenance fees | ||
STCH | Information on status: patent discontinuation |
Free format text: PATENT EXPIRED DUE TO NONPAYMENT OF MAINTENANCE FEES UNDER 37 CFR 1.362 |
|
FP | Lapsed due to failure to pay maintenance fee |
Effective date: 20101013 |